Senior Director, Regulatory Combination Product

About Us

Dianthus Therapeutics is a publicly traded, clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.

About The Role

As the Senior Director, Regulatory Combination Product, you will play a critical role in defining and driving regulatory compliance of our biologics-device combination products across their development lifecycles.

Reporting to the Vice President of CMC Regulatory Affairs, you will collaborate in a dynamic environment with device development, device quality, and CMC Team SMEs to support the development and commercialization of therapeutic products for rare diseases. You must have experience with biologics and combination products in order to be successful in this role. APFS or Auto-Injector experience specifically is highly preferred.

This is a unique opportunity to join a growing organization with an expanding pipeline. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

Effective communication skills will be critical to your overall success. You will be responsible for contributing to global regulatory strategies and collaborating with key stakeholders to execute the strategies in alignment with business priorities. You will provide guidance to cross-functional colleagues, throughout the design specification, design verification, design validation, and process validation, contributing to risk assessments and planning. Specifically, you will:

• Develop comprehensive strategies that address both biologic and device components and align with corporate goals and regulatory expectations.
• Provide guidance for plans and protocols for compatibility studies, design verification studies and functional stability studies, and contribute to the design of human factor studies and usability testing.
• Interpret regulatory regulations, standards, directives, guidelines and advise Development, Technical Operations, and Quality on their applicability to and impact on product development projects.
• Deliver strategic input to Design Control processes and documentation, ensuring alignment with health authority and notified body requirements and global technical standards. Review DHF documentation from a regulatory perspective.
• Design and execute effective submission strategies for device-related dossier components (INDs/CTAs, marketing applications, and post-approval changes) in collaboration with SMEs.
• Conduct precedent research to ensure creation of state-of-the-art studies.
• Influence cross-functional decision-making without direct authority, operating effectively in a matrixed environment.
• Perform assessment of change controls to identify and mitigate regulatory risks.
• Lead interactions with health authorities and notified bodies.
• Help manage device-related regulatory information in company systems.
• Support for other Regulatory CMC activities.

Experience

• A bachelor’s degree in a scientific/engineering discipline
• Experience as regulatory lead in pharmaceutical, biotechnology, or medical device industries, specifically with combination product filings. 
• Strong knowledge of and broad experience with regulations, standards, directives, guidelines and requirements related to the use of combination products in global clinical studies and commercial registration.
• Proven track record in late‑stage development of combination products.
• In-depth understanding of ISO and ASTM standards relevant to combination products.
• Solid understanding of current industry trends and regulatory expectations associated with combination products.
• Good understanding of ICH guidelines and GMP requirements for development and manufacturing of biologics.
• Strategic acumen, collaboration, influencing skills, and communication skills are important for success.